Kornimate/medical-research-clean huggingface dataset:
combining cereals with pulses - reduced gastrointestinal symptoms?

Conditions: Unidentified Gastrointestinal Symptoms Following Pulses Consumption

Summary: the aim of the study is to compare self-reported gastrointestinal symptoms and intestinal fermentation rates of the study products as measured by breath hydrogen and methane in adult population with self-reported mild abdominal sensitivity to pulses. the study products are a pulse products with two different cereals.

the study is a randomized, controlled, double-blind, cross-over intervention trial. the aim is to recruit 25 subjects to the trial. the study will be conducted with a cross-over setting, where the subjects will go through exposure meals and breath gas measurement two times (two different test products) in a randomized order. the study meals are identical in appearance but differ in fiber content. after study breakfast the breath gases are analyzed every 15 minutes during 8 hours.

Eligibility criteria:
inclusion criteria: * healthy subjects with subjective experience of gut symptoms after consumption of pulses * celiac disease and wheat allergy excluded by antigen test * age 18-65 * bmi 18,5 - 30 * normal liver, thyroid and kidney functions exclusion criteria: * celiac disease, crohn's disease, ulcerative colitis or acute diverticulitis * any medication affecting the gastrointestinal tract (e.g. laxatives and acid-suppressive drugs) * antibiotic treatment within previous 3 months * blood donation or participation to another clinical trial within one month prior to study entry
vinorelbine and gemcitabine combination in platinum resistant recurrent ovarian cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Summary: the purpose of this study is to evaluate the objective response rate and safety in platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer patients treated with vinorelbine and gemcitabine combination chemotherapy.

other objectives of this study are to evaluate progression-free survival and measure ca-125 response rate.

Eligibility criteria:
inclusion criteria: * participants must sign an approved informed consent form (icf) * histologically or cytologically confirmed epithelial ovarian/fallopian tube/primary peritoneal carcinoma * patients had to have received a front-line, platinum/taxane based chemotherapy regimen * patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer or progressed within six months of completing the most recent platinum-based chemotherapy * participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 3 prior systemic cytotoxic regimens. * patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area and increased ca 125 * a \>= 4 weeks interval between their last chemotherapy regimen and the start of study treatment * age 20-75 years old * performance status (who) 0-2 * life expectancy of at least three months * adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3) * adequate liver (bilirubin \< 1.5 times upper limit of normal and sgot/sgpt \< 2 times upper limit of normal) and renal function (creatinine \< 2 mg/dl) exclusion criteria: * prior therapy with vinorelbine or gemcitabine * treatment with \> 2 cytotoxic regimens (including primary platinum and taxane chemotherapy) * serious comorbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure, recent myocardial infarction or active infection. * concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ). * symptomatic central nervous system (cns) metastasis. * uncontrolled intestinal obstruction * other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational * pregnant or nursing.

Keywords: ovarian cancer
the impact of different relaxation techniques on psoriasis patients with an elevated psychological stress level

Conditions: Psoriasis; Stress, Psychological; Depression; Anxiety

Summary: two mind-relaxing techniques will be applied to psoriasis patients with an elevated psychological stress profile at baseline


Eligibility criteria:
inclusion criteria: * clinical diagnosis of psoriasis * adequate psychological stress profile * access to a personal computer/ laptop/ smartphone with internet connection * agreement to the informed consent form exclusion criteria: * other dermatological conditions which impair the life quality * psychological disorders under psychiatric treatment * hearing impairment * other on-going medical studies * pregnancy * aliteracy
attentional bias modification in fibromyalgia patients (abm)

Conditions: Fibromyalgia

Summary: there is a growing interest in the potential benefits of attentional bias modification (abm) training in chronic pain patients. however, studies examining the effectiveness of abm programs in fibromyalgia patients have demonstrated inconclusive effects on both behavioral indices and clinical symptoms. underlying neural dynamics of abm effects could yield additional insights but remain yet unexplored. current study, therefore, aimed investigating the effects of abm training on known neural indicators of attentional bias to pain using electroencephalography (eeg). the goal of this clinical trial is to test the effects of abm training on known neural indicators of attentional bias to pain using electroencephalography (eeg) in fibromyalgia patients the main question\[s\] it aims to answer are: * are fibromyalgia patients sensitive to abm procedures? * what are the neural indices associated with abm procedures? * do abm procedures transfer of effects on the clinical symptomatology in fibromyalgia patients? participants will performes five sessions consisting of a modified dot-probe task in which patients were trained to avoid facial pain expressions, whereas in the control group participants will performes five sessions consisting of a standard dot-probe task. potential abm training effects will be evaluated by comparing a single pre- and post-treatment session, in which event-related potentials (erps) will be recorded in response to three experimental tasks (standard dot-probe, rir, and visual tasks). furthermore, patients will fill a series of self-report questionnaires assessing anxiety, depression, pain-related worrying, fear of pain, fatigue and pain status. researchers will compare two fibromyalgia patients groups that will enrolled and randomly assigned to an abm training in order to see attentional improvements in the training fibromyalgia group.


Eligibility criteria:
inclusion criteria: * fibromyalgia diagnosis. * female sex * the presence of clinical symptoms regarding anxiety or depression will be not exclusion criteria, as long as fibromyalgia was participants' primary diagnosis. exclusion criteria: * participation in the study will require the absence of neurological and psychiatric disorders that impair cognitive functions (i.e., stroke brain damage, psychosis, bipolar disorder, and substance abuse/dependence). * pregnancy * not being able to read spanish in order to fill in the questionnaires

Keywords: attentional bias modification dot-probe task fibromyalgia erps pain-related faces
a self-help metacognitive therapy for cardiac rehabilitation patients (pathway ws3)

Conditions: Depression; Anxiety; Cardiac Rehabilitation; Psychological Distress

Summary: depression and anxiety are highly prevalent in people with heart disease, causing immense human and economic burden. available pharmacological and psychological interventions have limited efficacy and the needs of these patients are not being met in cardiac rehabilitation services despite emphasis in key nhs policy. extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. a psychological intervention called metacognitive therapy (mct) that reduces this style of thinking alleviates depression and anxiety in mental health settings. this is a single-blind feasibility randomised controlled trial of metacognitive therapy delivered in a self-help format (home-mct). the aim of the study is to evaluate the acceptability and feasibility of integrating home-mct into cardiac rehabilitation services and to evaluate the effectiveness and cost-effectiveness of home-mct.


Eligibility criteria:
inclusion criteria: 1. patients who are referred to the cr pathway who meet department of health (doh) and/or british association for cardiovascular prevention and rehabilitation (bacpr) cr eligibility criteria: * acute coronary syndrome used for any condition brought on by sudden, reduced blood flow to the heart * following revascularisation is the restoration of perfusion to a body part or organ that has suffered ischemia * stable heart failure * stable angina is chest pain or discomfort that most often occurs with activity or stress * following implantation of cardioverter defibrillators/cardiac resynchronisation devices * heart valve repair/replacement * heart transplantation and ventricular assist devices * adult congenital heart disease identified in adulthood * other (atypical heart presentation: nausea, dizziness, lower chest discomfort, upper abdominal pressure or discomfort that feels like indigestion and upper back pain) 2. a score of ≥ 8 on either the depression or anxiety subscale of the hospital anxiety and depression scale 3. minimum of 18 years old 4. competent level of english language skills exclusion criteria: 1. cognitive impairment which precludes informed consent or ability to participate 2. acute suicidality 3. active psychotic disorders (i.e., two \[or more\] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms). 4. current drug/alcohol abuse (a maladaptive pattern of drinking, leading to clinically significant impairment or distress) 5. concurrent psychological intervention for emotional distress that is not part of usual care 6. antidepressant or anxiolytic medications initiated in the previous 8 weeks 7. life expectancy of less than 12 months -
tyrosur® gel-investigation on wound healing efficacy

Conditions: Wounds; Wound Healing

Summary: this iia study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of tyrosur® gel after experimental impairment of the skin using an abrasive wound healing model.

this is a single-center, randomized, observer-blind phase iia study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of tyrosur® gel after experimental impairment of the skin using an abrasive wound healing model. in the investigation two small, superficial, abrasive wounds will be induced on the right forearm and one on the left forearm of each subject using a sterile surgical hand brush. these wounds will then be treated with the investigational products. the wound healing will be clinically assessed and photographs will be taken for documentation.

Eligibility criteria:
inclusion criteria: * men and women aged 18 years or older with healthy skin in the test area * the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant for the outcome of the clinical trial; * written informed consent obtained. exclusion criteria: * acne, suntan, eczema, hyperpigmentation or tattoos in the test fields; * dark-skinned persons whose skin color prevents ready assessment of skin reactions; * subjects with diabetes, psoriasis or lichen ruber planus; * history of wound-healing complications, or keloid and hypertrophic scarring; * evidence of drug or alcohol abuse; * pregnancy or nursing; * symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial; * known allergic reactions to components of the investigational product/s; * treatment with systemic or locally acting medications which might counter or influence the trial aim within two weeks before the baseline visit (e.g. antihistamines or glucocorticosteroids); * contraindications according to summary of product characteristics;
qiastat-dx® respiratory panel plus (rpp) clinical performance study

Conditions: Respiratory Disease

Summary: this study will evaluate the clinical performance of the qiastat-dx® respiratory panel plus (rpp) sars-cov-2 target with a validated comparator method

this multicentre study aims to evaluation the clinical performance of the qiastat-dx® respiratory panel plus (rpp) sars-cov-2 target with a validated comparator method

Eligibility criteria:
inclusion criteria: * presenting with signs and symptoms of a respiratory infection. * consent or assent to be obtained * able to communicate (speak, read and write) in local language, and able to understand and sign the required study documents. * willing and able to provide nasopharyngeal swab (nps) specimen collected per manufacturer's instructions. exclusion criteria: * subjects who, in the opinion of the investigator, are unsuitable for participation in the study.

Keywords: respiratory virus sars-cov-2 coronavirus
measuring the impact of integrating maternal and newborn hiv testing with childhood immunization services

Conditions: HIV

Summary: this randomized evaluation measured the impact of two levels of support for the integration of infant and postpartum maternal hiv testing with routine immunization services in southern zambia on the number of postpartum maternal hiv tests, infant hiv tests, and 1st dose diphtheria, pertussis, and tetanus (dpt1) vaccines.

this evaluation assessed two levels of support for the integration of early infant and maternal hiv testing with existing routine immunization services in rural health facilities in southern zambia with the aim of determining whether infant and postpartum maternal hiv testing rates would increase without harming immunization uptake. the evaluation randomized 60 health facilities to one of three study arms: 1) control (status quo); 2) simple intervention; and 3) comprehensive intervention. the simple intervention included restocking of hiv test kits and reminding health facilities of existing hiv testing guidelines by government health officials. the comprehensive intervention included the simple intervention components, as well as community sensitization, hands-on operational support to integrate services and improve patient flow, and opt-out hiv testing for mothers and infants according to existing guidelines. the change in the average number of monthly hiv tests and immunizations (dpt1) between the intervention period and baseline were compared between treatment and control facilities.

Eligibility criteria:
note that this evaluation used administrative data - no participants were enrolled for the main part of this study. participants were enrolled for the qualitative portions of the study. inclusion criteria: * mothers who had an infant within the past 18 months during the intervention period (oct 2013 - mar 2014) * infants who were at least six weeks of age and under six months of age during the intervention period (oct 2013 - mar 2014) * qualitative activities included facility staff and mothers and caregivers whose infants were due for their 6 week immunization during the intervention period. exclusion criteria: * mothers who did not have an infant within the past 18 months during the intervention period * infants who were less than six weeks of age during the intervention period or greater than six months of age throughout out the intervention period. * adults who were not mothers or caregivers with an infant due for his/her 6 week immunization during the intervention period were excluded from the qualitative activities.

Keywords: immunizations
study of obese patients comparing two vancomycin loading dose regimens

Conditions: Infection; Sepsis; Obesity

Summary: obesity alters the movement through the body of several antibiotics, including vancomycin. based on literature to date, total body weight should be used to determine dosages and shorter dosing intervals may be needed. however, hospitals have different approaches to managing vancomycin in this patient population. the most common example is not exceeding a dose of 2,000mg of vancomycin at one time in these patients. however, some institutions including the charleston area medical center do not have a set maximum one time dose. to date, a study has not been done comparing two different dosing regimens in obese patients to determine if having a maximum dose cap is beneficial. this research study is attempting to add to the limited existing body of literature regarding vancomycin dosing in obese patients. the investigators hypothesize that optimizing the initial or loading vancomycin dose that obese patients receive will decrease the time to target concentrations. for this study, obese adult patients will be randomized to receive either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg or 2) a loading dose of 20 mg/kg with a maximum dose of up to 4,000mg. the study's primary aim is to determine differences in the time needed to achieve target vancomycin concentrations and the occurrence of adverse events.


Eligibility criteria:
inclusion criteria: * patients ≥18 years of age who present to the charleston area medical center-memorial hospital emergency department * weight \>100kg * infection requiring intravenous vancomycin and admission to charleston area medical center-memorial hospital exclusion criteria: * any patient \<18 years of age * patients on dialysis or with unstable renal function (a change of \>0.5 mg/dl in scr concentration in patients with a scr of \<2 mg/dl or a 20% change in scr in patients with a scr of ≥2 mg/dl)
adc combined with hypofractionated radiotherapy, pd-1/pd-l1 sequential gm-csf and il-2 for treatment of her-2 positive advanced solid tumors(prag3.0)

Conditions: Carcinoma; Solid Tumor

Summary: this is an open-label, single-arm, phase ii investigator-initiated trial of antibody-drug conjugate combined with hypofractionated radiotherapy, pd-1/pd-l1 inhibitor sequential gm-csf and il-2 for treatment of advanced refractory solid tumors with her-2 positive


Eligibility criteria:
inclusion criteria: 1. aged 18 years and above; 2. diagnosed with histologically or cytologically-confirmed, her2-positive(ihc 1+, 2+ or 3+), standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy; 3. ecog(eastern cooperative oncology group) performance is 0-3; 4. life expectancy greater than 3 months; 5. t lymphocyte absolute value ≥0.5 upper limit of normal (uln), absolute neutrophil count(anc)≥1.0 x 10(9)/l；serum aspartate transaminase (ast) and serum alanine transaminase (alt) ≤3.0\*uln, or ast and alt≤5\*uln with hepatic metastasis; total serum creatinine ≤1.5\*uln； 6. signed informed consent form； exclusion criteria: 1. current pregnancy or lactation； 2. history of other malignant tumors within 5 years prior to dose administration, expect for：malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer); 3. uncontrolled epilepsy, central nervous system diseases or mental illness; 4. currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equal to class 2 congestive heart failure as defined by the new york heart association functional classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study; 5. received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 6. other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes; 7. allergic to any of the ingredients used in the study; 8. a history of immunodeficiency, including hiv positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy; 9. acute and chronic tuberculosis infection; 10. other disorders with clinical significance according to the researcher's judgment.
severe lung disease in childhood

Conditions: Lung Disease Chronic

Summary: only little information exists about the long term consequences of having severe lung disease in childhood. the patient population is heterogenous and the prognostic markers are few. this observational study will investigate which parameters that can be used to predict the outcome of having severe lung disease in childhood.

all patients aged 0-18 years at the hca childrens hospital with a severe lung disease will prospectively be registered in a database. at a yearly follow up, data from the patient record will be registered. informed consent from the patients and/or their parents will be obtained. registered data will include height, weight, results of lung function tests and imaging diagnostics. the study will provide knowledge of the prognosis of different lung diseases and how to monitor lung function in children.

Eligibility criteria:
inclusion criteria: severe lung disease - exclusion criteria: no informed consent -
psychological and physiological effects of different objects of breath meditation

Conditions: Physiological Stress; Psychological Stress; Emotions

Summary: the goal of this research is to test whether certain areas of focus in breath meditation are connected with certain mental health outcomes. the main question to be addressed is whether attention placed on the breath in the belly versus the nostrils during meditation results in differences in subjective experience, respiration and heart rate. participants will: * complete surveys * have heart rate and respiration measured * practice focused breathing participants can expect the study visit to last for one hour.

an online prescreen will determine eligibility. participants that 1) are under 18, 2) are not students currently enrolled at uw-madison 3) have previous mediation experience 4) obtain a high promis depression or anxiety score, or 5) have been diagnosed with one or more psychiatric disorders by a healthcare professional that will be listed in the pre-screen survey will be excluded. participants deemed eligible following prescreen will schedule a lab visit. at the beginning of the lab visit, participants will be provided a consent document and time to ask questions. after signing the consent form, researchers will place ecg leads and a respiration belt on participants, and then complete the baseline survey battery. participants will then sit at rest for 5 minutes of baseline heart rate and respiration data collection. next, participants will be randomly assigned in a counterbalanced order to nostril focus first or belly focus first and asked to follow a brief (\~5 minute) guided practice. after the practice, participants will complete a second battery of self-reports and then have a 10-minute period of rest/recovery. they will then complete the second practice (\~5 minutes) followed by a final survey. the entire session will take about an hour.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * student at uw madison * no major history of meditation practice exclusion criteria: * under 18 years of age * not currently enrolled at uw madison * have previous meditation experience * self-reports a mental health diagnosis

Keywords: meditation focus attention breath